BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P010021 · Decision Aug 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
    Trade Name
    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
    PMA Number
    P010021
    Device Class
    FDA Class 2
    Product Code
    MZO
    Generic Name
    Assay, enzyme linked immunosorbent, hepatitis c virus
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    August 30, 2001
    Date Received
    April 2, 2001
    Expedited Review
    N
    Docket Number
    01M-0536

    Advisory Committee Statement

    APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR. THESE DEVICES ARE INDICATED FOR: THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK IS INDICATED FOR THE IN VITRO QUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THREE RECOMBINANT HEPATITIS C VIRUS ENCODED ANTIGENS ARE USED. ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HEPATITIS C VIRUS (STATE OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS OR SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR IS INDICATED FOR USE IN THE CALIBRATION OF THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM FOR THE IN VITRO QUALITATIVE DETECTION OF IMMUNOGLOBULIN G ANTIBODY TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM AND PLASMA (HEPARIN, EDTA AND SODIUM CITRATE) USING VITROS ANTI-HCV REAGENT PACKS. THE VITROS ANTI-HCV CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus